ADMA Biologics Inc. announced the US FDA completed its Pre-Approval Inspection (“PAI”) of the Boca Raton, FL manufacturing facility related to ADMA's application for its VanRx SA25 Workcell aseptic fill-finish machine (“VanRx”). The PAI successfully concluded with the FDA issuing zero Form 483 observations in the Agency’s determination that the Company’s Boca Raton, FL facility continues to operate in compliance with the principles and guidelines of Good Manufacturing Practices (“GMP”) standards. The FDA’s review of ADMA’s VanRx regulatory filing remains ongoing, with anticipated regulatory approval in the second half of 2021.
“Through pandemic-related challenges, the successful completion of the FDA’s PAI for the VanRx demonstrates our continued adherence to GMP standards and speaks to our organization’s continued ability to deliver on regulatory commitments through unprecedented and challenging operating conditions,” said Adam Grossman, President and Chief Executive Officer of ADMA.
The VanRx fill-finish machine utilizes a state-of-the-art closed isolator design, allowing for greater automation to provide safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes. The combination of the recently FDA-approved increased BIVIGAM® manufacturing production scale as well as the enhanced vertical integration that will result from the anticipated approval of the VanRx machine will allow ADMA to bring its products to market faster, improve gross margins and substantially increase ADMA’s end-to-end control over its critical manufacturing process.
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